Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for patient-specific use. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers with a reliable source for compounded pharmaceutical preparations that are not commercially available.
The operations at our Longwood location are distinct from traditional compounding pharmacies. We operate on a larger scale under current Good Manufacturing Practices (cGMP), which are the same stringent quality standards required of conventional drug manufacturers. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets rigorous testing and safety protocols for potency, sterility, and purity. Our primary mission is to support the medical community by providing bulk quantities of essential medications for office use, enabling healthcare professionals to have critical drugs on hand for immediate patient care.
Our services are vital for hospitals, clinics, surgical centers, and other healthcare providers who require access to medications that may be in short supply or discontinued by large pharmaceutical companies. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize state-of-the-art technology and equipment within our facility to ensure precision and consistency in every batch. We are committed to upholding the trust placed in us by the medical community at our location on 2160 W State Road 434, Longwood, FL 32779, providing a critical component of the healthcare supply chain.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and offerings at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the FD&C Act. We are subject to FDA oversight and must adhere to Current Good Manufacturing Practices (cGMP), which involve rigorous testing and quality control standards beyond those of a traditional pharmacy.
2. Can I, as an individual patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy does not typically dispense medications directly to individual patients. Our facility at 2160 W State Road 434, Longwood, FL 32779 provides medications in bulk for office use by healthcare providers, such as physicians, hospitals, and clinics. You would receive your medication from your healthcare provider, who sources it from us.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in compounding sterile injectables, ophthalmics, and other preparations that are often on drug shortage lists or are not commercially available. All preparations are made in our facility at 2160 W State Road 434, Longwood, FL 32779 under strict cGMP standards to ensure safety and efficacy for healthcare providers to use.
4. How can a healthcare provider at a local clinic order from your facility?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide them through the process. Orders are prepared and shipped from our location at 2160 W State Road 434, Longwood, FL 32779 to the requesting healthcare facility.
5. Why would a healthcare provider at 2160 W State Road 434 use a 503B outsourcing facility?
Healthcare providers rely on our facility for a consistent, high-quality supply of medications that are critical for patient procedures and treatments but may be unavailable from standard manufacturers due to shortages or discontinuation. Using an FDA-registered 503B outsourcing facility like ours ensures they receive products that have undergone extensive quality testing.